Topical Timolol 0.5% in Atrophic Acne Scar

• ClinicalTrials.gov Identifier: NCT05597813
• Recruitment Status: Not yet recruiting
• First Posted: October 28, 2022
• Last Update Posted: February 21, 2023
• Sponsor: Zagazig University
• Information provided by (Responsible Party): Norhan Anees, Zagazig University

Tracking Information

• First Submitted Date: October 21, 2022
• First Posted Date: October 28, 2022
• Last Update Posted Date: February 21, 2023
• Estimated Study Start Date: March 1, 2023
• Estimated Primary Completion Date: October 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 25, 2022)

• Goodman and Baron's acne scar grading system [ Time Frame: through study completion, an average of 9 months ]
  Grade 1 Erythematous hypo or hyperpigmented flat marks Grade 2 Mild atrophy not obvious at social distance of >/=50 cm or easily covered by makeup or beard hair in male Grade 3 Moderate atrophy obvious at social distance of >/=50 cm, not easily covered by makeup or beard hair but able to be flattened by manual stretching of the skin Grade 4 Sever atrophy obvious at social distance >50 cm, not easily covered by makeup and not able to be flattened by manual stretching of skin
• Quartile grading system [ Time Frame: through study completion, an average of 9 months ]
  The improvement of patients is evaluated as follow: Poor (improvement < 25%) Mild (improvement 26%-50%) Good (improvement 51%-75%) Excellent (improvement >75%) (Saadawi et al., 2018)
• 5 point scale for evaluating patient's satisfaction [ Time Frame: through study completion, an average of 9 months ]
  None (no satisfaction) Mild (1%-25% satisfaction) Moderate (26%-50% satisfaction) Good (51%-75% satisfaction) Very good (76%-100% satisfaction) (El Domyati et al., 2015)
• Pain assessment [ Time Frame: through study completion, an average of 9 months ]
  Pain during the session will be assessed and graded as mild, moderat and sever (Saadawi et al., 2018).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Topical Timolol 0.5% in Atrophic Acne Scar
• Official Title: The Role of Topical Timolol 0.5% in Wound Healing and Scar Improvement Following Atrophic Acne Scar Microneedling
• Brief Summary: The aim of the study is to evaluate the efficacy and safety of microneedling combined with topical timolol 0.5% in the treatment of atrophic acne scars.

Detailed Description

Acne vulgaris (AV) is a common chronic inflammatory disease of skin that develops from sebaceous glands associated with hair follicles. Typically AV begins at puberty and may continue through adulthood affecting the comedogenic areas of face, back and chest (Mazzetti et al., 2019).

One of the undesirable outcomes of acne is acne scars that are divided into two main types based on a loss (atrophic) or gain (hypertrophic) of collagen. Atrophic type is the most common type, further subdivided into three subtypes: icepick, boxcar and rolling scar (Bahl et al., 2020).

Post acne scars occur in nearly 75% of patients with acne affecting both male and female equally (Khunger and Kumar, 2012). Acne scars impair quality of life and may be a risk factor for depression, suicide, low academic performance and unemployment (Sood et al., 2020).

There are different therapeutic modalities for atrophic acne scars including microneedling, chemical peeling, laser, filler, surgical procedures (punch excision, punch grafts) and fat transfer (Pavlidis and Katsambus, 2017).

Microneedling is considered safe for all skin types. It is performed by dermapen or dermaroller to induce new collagen formation that remains for a few months after the procedure (Cohen and Elbuluk, 2016).

Microneedling enhances the effect of topical preparations when used combined with them due to increasing their absorption by creating small channels through the epidermis to the dermis (Jaffe, 1981).

Ghassemi et al. (2021) observed that application of 0.5% timolol after TCA-CROSS caused a slight increase in scar improvement with more physician and patients' satisfaction.

Timolol, a beta-adrenergic receptor blocker, improves healing of skin wounds by increasing the phosphorylation of extracellular signal regulated kinases (ERK) leading to keratinocyte migration (Zeigler et al., 1999). Also, ERK initiate signaling cascades leading to fibroblast mitosis and proliferation with regulation of fibroblast functions in replacement of disorganized collagen and the reposition of the extracellular matrix (de Araújo et al., 2019).

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Acne Scars - Mixed Atrophic and Hypertrophic

Intervention

• Procedure: microneedling
  15 patients will be subjected to microneedling alone. Selected patients will receive one session with two weeks interval till complete clearance or up to 6 sessions.
• Procedure: microneedling with topical timolol 0.5%
  15 patients will be subjected to microneedling with topical timolol 0.5%.Selected patients will receive one session with two weeks interval till complete clearance or up to 6 sessions.

Study Arms

• Active Comparator: Group A
  microneedling group
  Intervention: Procedure: microneedling
• Active Comparator: Group B
  microneedling plus timolol group
  Intervention: Procedure: microneedling with topical timolol 0.5%

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 25, 2022): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 1, 2023
• Estimated Primary Completion Date: October 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. All types of facial atrophic acne scars
2. Patients aged >18 years
3. Both sexes

Exclusion Criteria:

1. Pregnancy and lactation
2. Active acne or any active facial lesion
3. History of keloid scar
4. History of systemic diseases as DM or hypotension
5. Bleeding and coagulation disorders
6. Infection and immunosuppression

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05597813
• Other Study ID Numbers: atrophic acne scars
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Norhan Anees, Zagazig University
• Original Responsible Party: Same as current
• Current Study Sponsor: Zagazig University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Zagazig University
• Verification Date: February 2023